This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
Bundle bundle-drug-product-excipients-pq-ex1 of type collection
Entry 1 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition
Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
description: Stelbatalol is formulated as an immediate-release, oral, solid dosage form in strengths of 20 mg of the free base equivalent. The 20 mg strength is presented as an orange, round, film coated tablet, debossed with '175' on one side.
combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000)
route: Oral use (standardterms.edqm.eu#20053000)
Names
ProductName Type Stalbatolol Proprietary (CodeSystem - Product Name Type#Proprietary) characteristic
Extension - Substance Property Range PQ: 23-27 mg/mL
type: Solubility purified water (CodeSystem - Substance Property#solubility-water)
characteristic
type: Water content (CodeSystem - Substance Property#water-content)
value: 23 mg/mL
Entry 2 - fullUrl = urn:uuid:1e82ce23-7c09-2248-7a29-d7c65a06616b
Resource Organization:
Generated Narrative: Organization
Resource Organization "1e82ce23-7c09-2248-7a29-d7c65a06616b"
identifier: id: 3010027651
name: Modified Sugar, Inc.
Contacts
Address 381 Main Street Lumberton New Jersey 08048 USA
Entry 3 - fullUrl = urn:uuid:1e82ce23-7c09-2248-7a29-d7c65a06616c
Resource Organization:
Generated Narrative: Organization
Resource Organization "1e82ce23-7c09-2248-7a29-d7c65a06616c"
identifier: id: 3012027651
name: Plasma Source, Inc.
Contacts
Address 351 Main Street Lumberton New Jersey 08048 USA
Entry 4 - fullUrl = urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "b89ed9d2-80f9-0cfb-70a1-5a6572e73a6b"
Extension - Novel Excipient PQ: true
Extension - Suitability for Use PQ: Excipient has been certified for use in human medicinal products
status: ACTIVE
for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)
role: Excipient (Ingredient Role#100000072082)
Manufacturers
Manufacturer See above (Organization/1e82ce23-7c09-2248-7a29-d7c65a06616b) substance
Codes
Reference See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380474)
Entry 5 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380474
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380474"
Names
Name Pegylated glucose SourceMaterials
Type CountryOfOrigin mineral (Substance Source Material Type#Mineral) United Kingdom (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#GBR)
Entry 6 - fullUrl = urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "b89ed9d2-80f9-0cfb-70a1-5a6572e73a7b"
Extension - Suitability for Use PQ: Excipient is derived from plasma certified to originate from healthy animals and is irradiated prior to distribution. In addition, albumin is not prepared with the use of other ruminant materials.
status: ACTIVE
for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)
role: Excipient (Ingredient Role#100000072082)
Manufacturers
Manufacturer See above (Organization/1e82ce23-7c09-2248-7a29-d7c65a06616c) substance
Codes
Reference See above (SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380475)
Entry 7 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380475
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380475"
Names
Name Deactivated goat albumin SourceMaterials
Type Species Part CountryOfOrigin animal (Substance Source Material Type#Animal) animal (Substance Source Material Part#Animal) animal (Substance Source Material Type#Animal) United States of America (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#USA)